Now that President Obama has signed historic food-safety legislation into law, the coalition of food industry, public interest and consumer groups that supported the new law must convince the new Congress – including the majority Republican House of Representatives pledged to shrink the federal bureaucracy – to fund it. The law aims to shift the….
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Pharmacists worldwide worry about drug counterfeiting
There is growing concern among pharmacists in developed countries, including the U.S., that drug counterfeiting is a serious problem that current policies and technology have been unable to solve. In a recently published survey commissioned by Pfizer and the International Pharmaceutical Federation (FIP), 63% of 2,000 community, retail and hospital pharmacists in the U.S., Europe….
Continue ReadingPatient safety at risk if testing standards for biosimilars are relaxed, FDA told at hearing
Patient safety advocates and brand-name drug makers lined up against companies that make generic drugs over just how flexible the standards should be for the clinical testing of biosimilars. These drugs, also known as biogenerics, follow-on biologics and subsequent entry biologics, are officially approved subsequent versions of biopharmaceutical products following patent and exclusivity expiration on….
Continue ReadingFDA recalls infusion pump and tissue stabilizer
The Food and Drug Administration has issued Class I recalls of Hospira Symbiq One- and Two-Channel infusers and Medtronic Octopus Nuvo tissue stabilizers. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or….
Continue ReadingEight years on, diet drug Meridia withdrawn from market
A diet drug which safety advocates called to be withdrawn from public use eight years ago has finally bit the dust. Under pressure from the Food and Drug Administration, the drug’s manufacturer, Abbott Laboratories, voluntarily pulled the drug from the market due to longstanding concerns that it increased the risk of heart attacks and strokes…..
Continue ReadingNew alliance creates tools to reduce pain medication misuse
A new patient safety organization has launched a range of online tools and other resources to reduce abuse of opioids by identifying the risks associated with their use. The materials from the CARES Alliance (Collaborating & Acting Responsibly to Ensure Safety) include several “safe-use” programs, tools and educational materials for patients, caregivers and healthcare providers…..
Continue ReadingRadiation Overdoses and Regulatory Ineptness
When is a radiation overdose not an overdose? When the facility giving the CT scans says so. At least that’s what the Food and Drug Administration concluded when it dropped a safety investigation of the Huntsville, Alabama Hospital. Now the FDA, which monitors radiation safety for the medical industry, is considering re-starting its investigation, once….
Continue ReadingThe Medical Industry’s Own “Steroids in Baseball” Scandal
Another reason for careful patients to be skeptical about overly hyped prescription drugs came this week with news about the extent to which articles in important medical journals are “ghost-written” by drug manufacturers. According to an article in the New York Times by Natasha Singer, newly released papers from lawsuits involving Wyeth’s hormone replacement drugs….
Continue ReadingAcetaminophen (Tylenol): More Reason for Caution
Acetaminophen, the unpronounceable name for the active ingredient in Tylenol, is the most widely used pain reliever in the United States. But it can destroy the liver in ordinary or near-ordinary doses. That fact is news to many consumers but is old hat to liver specialists who every week treat patients at death’s door from….
Continue ReadingBotox Now Required to Carry Black-Box Warning Label
One day after the FDA approved a new antiwrinkle drug (Dysport) in April 2009, the agency issued a new requirement that these drugs must carry a “black-box” warning label, the strongest safety warning typically reserved for drugs with very serious risks, Natasha Singer reports in a New York Times story. A popular antiwrinkle drug in….
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